Aetion, a Datavant Company

Aetion, now a Datavant company, provides software and services for generating real-world evidence (RWE) from healthcare data. The company serves life sciences developers, regulators, and healthcare purchasers, helping them understand how medical innovations perform in actual clinical practice. Their Aetion Evidence Platform combines validated analytical methods, data ingestion tools, and pre-built workflows to transform real-world data into decision-grade evidence.

The platform includes four product modules: Discover for rapid data visualization, Activate for streamlined data preparation, Substantiate for regulatory-grade evidence generation, and Generate for privacy-preserving synthetic data. Aetion's approach emphasizes validated methods, reproducible studies, and compliance with regulatory standards. Their services range from scientific feasibility assessments to bespoke RWE studies including clinical trial emulation and external control arm development.

The company reports that 17 of the top 20 global biopharmaceutical companies use their solutions, and they work with 47+ data provider partners. Founded by Harvard Medical School faculty with deep pharmacoepidemiology expertise, Aetion has established relationships with regulatory bodies including the FDA and EMA, and participates in initiatives like the GetReal Institute.

Organizations should consider Aetion when they need to generate regulatory-quality real-world evidence that meets stringent FDA, EMA, or HTA body standards. The platform excels in scenarios requiring validated analytical methods, reproducible study designs, and transparent documentation for regulatory submissions or post-approval commitments.

Engagements typically involve either software platform licensing for internal RWE teams or full-service evidence generation where Aetion's epidemiologists design and execute studies. Clients can expect rigorous methodology, accelerated timelines compared to traditional approaches, and evidence packages structured for regulatory acceptance.

Aetion exclusively serves the healthcare and life sciences sectors, with particular emphasis on pharmaceutical, biotechnology, and medical device manufacturers navigating regulatory pathways. The company's real-world evidence capabilities address specific healthcare regulatory requirements including FDA post-approval commitments, EMA evidence standards, and health technology assessment body submissions.

Their work spans therapeutic areas requiring complex epidemiological analysis, including oncology, HIV, and chronic disease management. The platform supports healthcare-specific data sources including electronic health records, administrative claims, and specialty registries, with methodologies designed to address healthcare data quality challenges like information bias and confounding.

The ideal client is a pharmaceutical, biotechnology, or medical device company with annual revenue exceeding $500 million that needs to generate real-world evidence for regulatory submissions, post-market requirements, or market access. These organizations typically have established clinical development teams, existing relationships with data providers, and evidence generation budgets aligned with regulatory milestones requiring validated methodologies and transparent documentation.